Patient interface device with limited support area on the face

ABSTRACT

A patient interface device includes a support member, a sealing assembly attached to the support member, and a pair of contacting members. The contacting members are coupled to the support member on each side of the sealing assembly. The contacting members are each configured and arranged to contact the user over a limited contacting region, which corresponds to a junction of the orbicularis oris facial muscle, the zygomaticus facial muscle, and the risorius facial muscle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation under 35 U.S.C. §120 of U.S. patentapplication Ser. No. 14/224,691, filed Mar. 25, 2014, which is aContinuation under 35 U.S.C. §120 of U.S. patent application Ser. No.11/799,802, filed May 3, 2007, now U.S. Pat. No. 8,701,667, granted Apr.22, 2014, which claims priority under 35 U.S.C. §119(e) from provisionalU.S. Patent application No. 60/798,454, filed May 5, 2006, the contentsof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a patient interface device thatprovides a stable platform supporting a sealing assembly that couples aflow of gas with an airway of a patient, is relatively small to minimizethe amount of material supported on the patient's face and head, and yetprovides a high degree of adjustability, so that the patient interfacedevice fits comfortably on a wide variety of differently sized andshaped patients.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in the esophagus. For example, it is known to ventilate apatient using a technique known as non-invasive ventilation. It is alsoknown to deliver continuous positive airway pressure (CPAP) or variableairway pressure, such as a bi-level pressure that varies with thepatient's respiratory cycle, or an auto-titrating pressure that varieswith the monitored condition of the patient. Typical pressure supporttherapies are provided to treat a medical disorder, such as sleep apneasyndrome, in particular, obstructive sleep apnea (OSA), or congestiveheart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support system with the airway of the patient so that a flow ofbreathing gas can be delivered from the pressure/flow generating deviceto the airway of the patient. It is known to maintain such masks on theface of a patient by a headgear assembly, which typically have upper andlower straps that wrap around the user's head, where each strap hasopposite ends threaded through connecting elements provided on theopposite sides and/or top of a mask.

Because such masks are typically worn for an extended period of time, avariety of concerns must be taken into consideration. For example, inproviding CPAP to treat OSA, the patient normally wears the patientinterface device all night long while he or she sleeps. One concern insuch a situation is that the patient interface device is as comfortableas possible, otherwise the patient may avoid wearing the interfacedevice, defeating the purpose of the prescribed pressure supporttherapy. It is also important that the interface device provides a tightenough seal against a patient's face without discomfort. A problemarises in that in order for the mask to maintain a seal without anyundue gas leaks around the periphery of the mask, the mask cushion maybe compressed against the patient's face. This is most notable, forexample, in masks having a bubble type cushion. While the bubble cushionitself is comfortable, it does not provide adequate support, which maycause gas leaks around the periphery of the mask. The bubble effect isdiminished when the headgear strap force is increased to improvestability.

Some conventional respiratory masks attempt to enhance mask stability byproviding a relatively large structure that must be mounted on thepatient's face. Therefore, an advantage exists for a respiratory maskthat minimizes the amount of material that must be supported on thepatient's head and face, yet provides a relatively high degree ofstability, so that that the mask is not easily dislodged from thepatient. Another advantage exists for a respiratory mask that providesthe headgear strapping force needed to hold the mask on the patient tolocations on the patient's face that are best suited to handle suchforces.

A further advantage exists for a respiratory mask that avoids providingany structural features near the patient's eyes. This advantage isparticularly important for patient's who desire to where glasses whilewearing the mask and for patient's that tend to feel claustrophobic whena structure is provided at or near their eyes. Avoiding the ocular areaalso eliminates or avoids the leakage of gas into the user's eyes, whichcan cause great discomfort. A still further advantage exists for a maskthat accomplishes these functions while also providing a relatively highdegree of adjustability, so that a common mask style or configurationcan be fitted to a variety of differently sized and shaped patients.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface device that overcomes the shortcomings of conventionalpatient interface assemblies. This object is achieved according to oneembodiment of the present invention by providing a patient interfacedevice that includes a support member and a sealing assembly attached tothe support member. The sealing assembly contacts the user andcommunicates a flow of gas to an airway of the user. To stabilize andposition the patient interface device on the user, the patient interfacedevice also includes a first contacting member operatively coupled tothe support member on a first side of the sealing assembly and a secondcontacting member operatively coupled to the support member on a secondside of the sealing assembly opposite the first side. The firstcontacting member and the second contacting member are each configuredand arranged to contact such a user over a limited contacting region.This limited contacting region corresponds to a junction of theorbicularis oris facial muscle, the zygomaticus facial muscle, and therisorius facial muscle.

It is a further object of the present invention to provide a system fordelivering a flow of gas to a user using the patient interface devicedescribed above.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural references unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, and 1C are front, side, and bottom exterior views,respectively, of a human face illustrating the exterior location wherethe contacting members of the patient interface device of the presentinvention contact the surface of the user;

FIGS. 2A-2C are side perspective views of the human facial muscles, andFIG. 3 is a side perspective view the human facial muscles illustratingthe location, relative to the facial muscles, where the contactingmembers are located on the user during normal use;

FIGS. 4A and 4B are front and side skeletal views, respectively, of ahuman skull illustrating the skeletal features where the contactingmembers are located on the user during normal use;

FIGS. 5 and 6 are rear and front perspective views, respectively of afirst embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 7 is an exploded view of the patient interface device of FIG. 5;

FIGS. 8-10 are rear, front, and size perspective views, respectively, ofthe support member, sealing assembly, and contacting members in thepatient interface device of FIG. 5;

FIGS. 11 and 12 are rear and front perspective views, respectively of asecond embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 13 is an exploded view of the patient interface device of FIG. 11;

FIG. 14 is a cross-sectional view of the patient interface device ofFIG. 11 taken alone line 14-14 of FIG. 12;

FIG. 15 is a cross-sectional view of the patient interface device ofFIG. 11 taken alone line 15-15 of FIG. 11;

FIG. 16 is a cross-sectional view of the patient interface device ofFIG. 11 taken alone line 16-16 of FIG. 11;

FIGS. 17-18 are rear and front perspective views, respectively of athird embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 19 is a cross-sectional view of the patient interface device ofFIG. 17 taken alone line 19-19 of FIG. 17;

FIG. 20 is a cross-sectional view of the patient interface device ofFIG. 17 taken alone line 20-20 of FIG. 17;

FIG. 21 is a perspective view showing a patient wearing the patientinterface device of FIG. 17;

FIGS. 22 and 23 are rear and front perspective views, respectively, of afourth embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 24 is an exploded view of the patient interface device of FIG. 22;

FIG. 25 is a cross-sectional view of the patient interface device ofFIG. 22 taken alone line 25-25 of FIG. 22;

FIG. 26 is a perspective view showing a patient wearing the patientinterface device of FIG. 22;

FIGS. 27 and 28 are rear and front perspective views, respectively, of afifth embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 29 is an exploded view of the patient interface device of FIG. 27;

FIG. 30 is a cross-sectional view of the patient interface device ofFIG. 27 taken alone line 30-30 of FIG. 28;

FIG. 31 is a perspective view showing a patient wearing the patientinterface device of FIG. 27;

FIGS. 32 and 33 are rear and front perspective views, respectively, of asixth embodiment of a patient interface device according to theprinciples of the present invention;

FIG. 34 is an exploded view of the patient interface device of FIG. 32;

FIG. 35 is a cross-sectional view of the patient interface device ofFIG. 32 taken alone line 35-35 of FIG. 33;

FIG. 36 is a perspective view showing a patient wearing the patientinterface device of FIG. 32; and

FIGS. 37 and 38 are front and rear perspective views, respectively, of aseventh embodiment of a patient interface device according to theprinciples of the present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The present inventors recognized that there are certain locations on thehuman face that are better suited to support the force needed to hold apatient interface device on the patient than other locations. To takeadvantage of this, a patient interface device and various embodimentsthereof have been developed or proposed that provide a seal around theairway and contact the user at the locations on the patient's face thatare best suited to handle the headgear strapping forces.

To understand what location on the head/face the present inventorsidentified and that serves as the location where the patient interfacedevice of the present invention is supported on the user, the humananatomy is considered from both an external view and an internal view.From the internal view, the human anatomy is considered from both themuscular system and the skeletal system. FIGS. 1A and 1B illustrate theexterior view of the human face, FIGS. 2A-2C and 3 illustrate the humanfacial muscles, and FIGS. 4A and 4B illustrate the skeletal system ofthe human face. The location of the contacting members is shown as ahighlighted region in each figure.

In all these figures, the patient interface device of the presentinvention includes patient contacting features, such as pads and padsupports described in greater detail below, that contact a first region20 and a second region 30 on the surface of the user in an area belowthe eyes and above the mouth. Regions 20 and 30 represent the largestarea on the user below the eyes and above the mouth at which thecontacting members of the patient interface device contact the user.These regions are disposed on each side of a midline 22 of the head atthe front of the face. Please note that FIGS. 1B, 3, and 4B illustrateonly one of these two regions due the nature of the illustration being aside view of the human head.

It should be noted that the patient interface device also contacts aportion or the user, typically, but not necessarily near, the airway(such as the nares 14 a, 14 b, mouth 24, or both), to seal the airway.This is necessary so that a flow of gas can be provided to and receivedfrom the user with little or no leakage of gas at the interface betweenthe sealing assembly of the patient interface device and the surface ofthe user. It should be understood that this sealing function isdistinguishable from the support function provided by the contactingmembers of the patient interface device, which contact first region 20and second region 30. The support function keeps the patient interfacedevice located on the user at the proper position, and, in particular,keeps the sealing assembly of the patient interface device at the properorientation, location, angle of attack, etc. relative to the airway. Thesupport function also stabilizes the mask on the surface of the user.

Referring now to FIGS. 1A and 1B, regions 20 and 30 are located abovemouth 24, and, more particularly, above each side portion 26 a and 26 bof the mouth. Regions 20 and 30 are also located below each respectiveeye 28 a and 28 b generally offset from iris 32 a and 32 b towardmidline 22. Regions 20 and 30 also generally overlie a nasolabial fold34, which is the crease that runs from the flanks or sides of nose 26 tothe corner of the mouth. The nasolabial fold separates the cheek fromthe upper lip. When properly positioned, the patient contacting portionsgenerally rest on top of the nasolabial fold in between the nose and thelips.

Regions 20 and 30 also lie generally, but not necessarily completelybelow the lowest portion of the nose. Regions 20 and 30 do not extend tothe mouth, do not touch any part of the nose, and do not extend over thecheeks, or cheek bones, as discussed in greater detail below. Inaddition, regions 20 and 30 are aligned with one another along an arc38, that extends below the nose and above the mouth.

To better understand where regions 20 and 30 are located on the head ofthe user, reference is now made to FIGS. 2A-2C and C, which illustratethe human facial muscles. Regions 20 and 30 are located at the junctionor confluence of the following three facial muscles on each side of theface: (a) the orbicularis oris 40, which is highlighted for illustrativepurposes in FIG. 2A; (b) the zygomaticus 42, which is highlighted forillustrative purposes in FIG. 2B; and (c) the risorius 44, which ishighlighted for illustrative purposes in FIG. 2C. As shown in FIG. 3,these three muscles converge at a specific region on the human head,which has a generally concave contour. The contacting members (pads, padsupports) in the patient interface device of the present invention aresupported on the surface of the user at this location, which is an areaapproximately 300 mm² in size and does not extend beyond this area.

FIGS. 4A and 4B illustrate the human facial bones in a still furtherattempt to describe the location of regions 20 and 30 where thecontacting members overlie the skeletal features of the user when thepatient interface device is properly positioned on the user. As can beappreciated from reviewing these figures, regions 20 and 30 are providedon maxilla 46 at a canine fossa region 48, which includes the valley atthe base of zygomatic bone 50. Regions 20 and 30 can push up against thelower portion of the zygomatic bones but do not overlie the zygomaticbones. It should be emphasized that regions 20 and 30 cover only alimited area on the user, as described above in FIGS. 1A-4B and do notextend beyond this area. Thus, regions 20 and 30 do not overlie thezygomatic bones.

FIGS. 5-10 illustrate a first embodiment of a patient interface device100 according to the principles of the present invention. Patientinterface device 100 is shown in FIG. 6 schematically connected to aventilator or pressure support system 10 via a patient circuit 12, whichcommunicates gas from the pressure support system to the patientinterface device. For purposes of the present invention, pressuresupport system 10 is any conventional ventilation or pressure supportsystem that includes a gas flow generating device capable of deliveringa flow of gas to the user. Patient circuit 12 is any device, such as aflexible tubing, that carries the flow of gas from the pressure/flowgenerator in the pressure support system to the patient interfacedevice. In this schematic illustration, the patient circuit includes asingle hose that is coupled to the pressure support system, aY-connector or Y-junction, and two separate hoses that diverge from theY-connector and are connected to each side of the patient interfacedevice.

Examples of pressure support systems include, but are not limited to: aventilator, continuous positive airway pressure (CPAP) device, or avariable pressure device, e.g. an auto-titrating device, proportionalassist ventilation (PAV®) device, proportional positive airway pressure(PPAP) device, C-Flex™ device, Bi-Flex® device, or a BiPAP® devicemanufactured and distributed by Respironics, Inc. of Pittsburgh, Pa., inwhich the pressure provided to the patient varies with the patient'srespiratory cycle so that a higher pressure is delivered duringinspiration than during expiration, or other pressure support device.

Patient interface device 100 includes a support member 102 in the formof a tubular portion having an internal passage or lumen 106 that servesas a pathway for the flow of gas to and from the user. In theillustrated embodiment, both ends of support member 102 are coupled topatient circuit 12. However, the present invention also contemplatescoupling only one end of the support member to the patient circuit andcapping or otherwise blocking or sealing the other end of the supportmember. A coupling member, such as an elbow joint or flexible sleeve,(not shown in this embodiment) can be provided at the end or ends ofsupport member 102 to couple the support member to the patient circuit.

A sealing assembly 104 is operatively coupled to support member 102. Inthe embodiment of FIGS. 5-10, sealing assembly 104 is a pair of nasalprongs 105 a and 105 b that seal against the nares of the user. A gasflow path 106 is provided in support member 102 and openings 108 a and108 b are provided in each prong to communicate gas from thepressure/flow generating system to the airway of the user when thepatient interface device is donned by the user. In the illustratedembodiment, each prong has a general “mushroom” configuration with astem portion and a head portion, both of which are formed from aflexible material, such as silicon. Of course, the portions of theprongs can be formed from different materials. For example, the head canbe formed of foam or gel and the stem formed from silicon. In addition,the nasal prongs can have a variety of configurations, such asdome-shaped, and can have other features, such as bellows, pleats, andgrooves that enable the position, orientation, or angle of the prongs tomove or be adjusted to match the anatomical features of the user.Examples of other nasal prongs suitable for use in the sealing assemblyof the present invention are described in U.S. patent application Ser.No. 11/074,410 (publication no. 20050199242)(“the '410 application”) thecontents of which are incorporated herein by reference and in U.S.patent application Ser. No. 11/048,680 (publication no.US-2005-0205096-A1) the contents of which are incorporated herein byreference.

A first contacting member 110 is operatively coupled to support member102 on a first side of sealing assembly 104. Likewise, a secondcontacting member 120 is operatively coupled to the support member on anopposite side of the sealing assembly from the first side. Firstcontacting member 110 is configured and arranged to contact a user overonly region 20, as defined above with respect to FIGS. 1-4B. Similarly,second contacting member 120 is configured and arranged to contact auser over only region 30, as defined above.

A first pad 112 is provided on first contacting member 110, and a secondpad 122 is provided on second contacting member 120. Pads 112 and 122are shaped, sized, and configured to contact only regions 20 and 30noted above. The pads are joined to the contacting member, permanentlyor removably, using any conventional technique. For example, the padscan be adhered to the contacting members to provide a permanentattachment. The pads and contacting members can be configured such thatthe pads snap onto or slip onto the contacting members. Pads 112 and 122can be made from any suitable material or combination of materials, suchas gel, foam, silicon. Example of gel materials suitable for use as pads112 and 122 are described in U.S. Pat. Nos. 5,647,357; 5,884,624;6,397,847; and 6,895,965 and pending U.S. provisional patent applicationSer. No. 11/715,760 (“the '760 application”)(collectively referred to as“the gel references”), the contents of each of which are incorporatedherein by reference. The present invention contemplates that pads 112and 122 can be omitted. In which case, the surface of first and secondcontacting members 110 and 120 can be configured so as to be comfortableto the user.

In the illustrated embodiment, first and second contacting members 110and 120 are generally flexible or semi-rigid members so that they candeform as the patient interface device is forced against the surface ofthe user, typically by tightening the headgear. The present inventioncontemplates that first and second contacting members 110 and 120 areconnected to support member 102 using any conventional technique. In theembodiment of FIGS. 5-10, the first and second contacting members areintegral with support member 102, for example, by forming both at leasta portion of the support member and the contacting members from a commonmaterial. Indeed, the present invention even further contemplatesforming at least a portion of support member 102, sealing assembly 104,and contacting members 110 and 120 as a unitary element 130, an exampleof which is shown in FIGS. 8-10.

In an exemplary embodiment, unitary element 130 is an injection moldedpart that is formed from a flexible material, such as silicon. Thisprovides the flexibility needed for sealing assembly 104 and contactingmembers 110, 120. However, in an exemplary embodiment, support member102 is formed from a rigid or semi-rigid material, so as to providestructural integrity for the patient interface device. To providestructural support for support member 102 in this embodiment, a supportelement 132, which is rigid or semi-rigid member, is provided as acomponent of the support member. The support member is formed byassembling support element 132 within unitary element 130, for example,by inserting the support element into the unitary element. In anexemplary embodiment, support element 132 is formed from a rigid plasticand is generally tubular.

To maintain unitary element 130 in an assembled relation with supportelement 132, the present invention contemplates providing anattachment/alignment mechanism for engaging these two elements together.In this embodiment, grooves 134 are provided in unitary element 130 andprotrusions 136 are provided in support element 132. When the unitaryelement is properly assembled with the support element, protrusions 134are seated in grooves 134. Thus, the protrusions and grooves also serveto ensure that unitary element 130 is properly aligned on or attached tosupport element 132. It is to be understood that the present inventioncontemplates using any conventional technique for attaching unitaryelement 130 with support element 132, such a clamps, friction fitting,adhesive, bonds, or welds. In addition, the size, shape, configurationand location of the protrusions 136 and grooves 134 can be varied,including providing the grooves in support element 132 and providing theprotrusion on unitary element 130.

To couple a headgear (not shown) to patient interface device 100, thepatient interface device of the present embodiment includes a supportframe 140 that is operatively coupled to support member 102. Theheadgear, and, in particular, the headgear straps, attach to supportframe 140 using any conventional technique. In the illustratedembodiment, slots 142 are provided into which the headgear strapsinsert. Of course, any fastening technique for joining the headgearstrap to the support frame are contemplated by the present invention,including snaps, hooks, loops, clamps, or other connectors. Examples offastening techniques suitable for use with the present invention aredescribed in U.S. patent application Ser. No. 10/629,366 (publicationno. US-2004-0025883-A1)(“the '366 application”), the contents of whichare incorporated herein by reference.

Support frame 140 can be rigid, semi-rigid, or even non-rigid structureso long as it accomplishes the function of translating the strappingforce of the headgear to the patient contacting portions of the patientinterface device, i.e., sealing assembly 104 and contacting member 110,120. Support frame 140 can be coupled to support member 102 in anymanner. However, in the illustrated embodiment, the support member isinserted into openings 144 provided in the support frame.

To ensure that support member 102 is properly assembled with supportframe 140, the present invention contemplates providing an alignmentmechanism that orients the support member to the support frame. In theillustrated embodiment, the alignment mechanism includes a protrusion146 is provided on support member 102 and an opening or slot 148 isprovided on support frame 140. To properly assemble the support memberto the support frame, the protrusion is seated in slot 148. This isaccomplished, for example, by rotating the support member in the supportframe and/or sliding one relative to another until alignment is reached.It is to be understood that the present invention contemplates using anyconventional technique for attaching support member 102 with supportframe 140, such a clamps, friction fitting, adhesive, bonds, or welds.In addition, the size, shape, configuration and location of theprotrusions 146 and slot 148 can be varied, including providing theopening in support member 102 and providing the protrusion on thesupport frame 140.

Patient interface device 100 includes an exhaust assembly 150 to ventgas from the interior of the patient interface device to ambientatmosphere, which is necessary in a non-invasive type of gas deliverysystem. The present invention contemplates that exhaust assembly 150 canhave any configuration, so long as the function of exhausting asufficient amount of gas to atmosphere is achieved. For example, theexhaust assembly can be configured to provide a continuous flow rate forthe venting of exhaust gas to atmosphere, or can be configured toprovide a variable flow rate; dependent, for example, on the pressure ofthe gas in the closed system.

In the illustrated embodiment, exhaust assembly 150 is defined by aplurality of vent holes provided in the wall of support member 102. Thenumber, size, hole pattern, and shape of the holes can have anyconfiguration. One example of a multiple-hole type of exhaust assemblysuitable for use in the present invention is disclosed in U.S. patentapplication Ser. No. 10/119,673 (publication no. 2003/0005931), thecontents of which are incorporated herein by reference. It should alsobe noted that only one exhaust assembly need be provided on the patientinterface device, so long as the exhaust flow rate is sufficient toprovide an adequate exhaust gas venting function. The exhaust assemblycan also be omitted if exhausting gas from the system is not needed orif the exhaust assembly is provided elsewhere, such as in the patientcircuit.

FIGS. 11-16 illustrate a second embodiment of a patient interface device200 according to the principles of the present invention. Patientinterface device 200 includes a support member 202 and a sealingassembly 204 coupled to support member. Support member 202 includes aninternal passage or lumen 206 that serves as a pathway for the flow ofgas to and from the user. As in the previous embodiment, one or bothends of support member 202 are coupled to a pressure support system.

Sealing assembly 204 is a pair of nasal prongs 205 a and 205 b withopenings 208 a and 208 b provided in each prong to communicate gas inlumen 206 to the airway of the user. As in the previous embodiment, eachprong has a “mushroom” configuration with a stem portion 207 a, 207 band a head portion 209, 209 b. Of course, other embodiments for thenasal prongs, as well as the entire sealing assembly are contemplated bythe present invention. For example, the sealing assemblies set forth insubsequent embodiments are contemplated for use in the presentembodiment.

A unitary element 230 in combination with a support element 232 definesupport member 202. An opening 235 is provided in support element 232,and unitary element 230 is configured to fit over the opening in thesupport element and enclose the opening. This same configuration can beused in the previous embodiment. In an exemplary embodiment of thepresent invention, unitary element 230 is formed form a flexiblematerial and support member 202 is formed from a rigid material. Inaddition, unitary element 230 is configured so as to dip into opening235, as perhaps best shown in FIGS. 14-16, to keep the profile of thepatient interface as small as possible.

To connect and align unitary element 230 with support element 232,grooves 234 are provided in the unitary element and protrusions 236 areprovided in the support element. When the unitary element is properlyassembled with the support element, protrusions 234 are seated ingrooves 234. Of course, other techniques for mating the support elementto the unitary element are contemplated by the present invention. Inaddition, it is to be understood that grooves 234 and protrusions 236can be omitted entirely. Exhaust assemblies 250, in the form of aplurality of vent holes defined in the wall of support member 202, areprovided to vent gas from the interior of the patient interface deviceto ambient atmosphere.

As in the previous embodiment, a support frame 240 is coupled to supportmember 202. A headgear (not shown) is coupled to the support frame viaslots 242. Of course, any technique for attaching the headgear to thesupport frame is contemplated by the present invention. In thisembodiment, the first and second contacting members are eliminated infavor of coupling a first pad 212 and a second pad 222 to support frame240. Pads 212 and 222 are shaped, sized, and configured to contact onlyregion 20, 30 in the face of the user and are joined to the supportframe, permanently or removably, using any conventional technique. Inaddition, pads 212 and 222 can be made from any suitable material, suchas gel, foam, silicon. The present invention also contemplates that thepads are rotatably coupled to the support frame such that they rotate asindicated by arrow A.

Support frame 240 can be rigid, semi-rigid, a non-rigid structure, orany combination thereof so long as it accomplishes the function oftranslating the strapping force of the headgear to the patientcontacting portions of the patient interface device, i.e., sealingassembly 204 and pads 212 and 222. Protrusions 236 can be used to helpmaintain the support frame on the support member by extending theprotrusions beyond the surface of the support member to server as astopper for outward movement of the support member.

Support frame 240 is coupled to support member 202 in any suitablemanner. However, in the illustrated embodiment, the support member isinserted into openings 244 provided in the support frame. A protrusion246 is provided on support element 232 and an opening or slot 247 isprovided in unitary element 230 to receive the protrusion. In addition,a further opening or slot 248 is provided in support frame 140. Toproperly assemble support member 202 to the support frame, protrusion246 is seated in slot 248. In this embodiment, walls 249 are providedaround slot 247, which also insert into slot 248.

FIGS. 17-21 illustrate a third embodiment of a patient interface device300 according to the principles of the present invention. Thisembodiment is generally similar to that of FIGS. 11-16 in that a sealingassembly 304 is mounted onto a support member 302, and first and secondpads 312 and 322 are coupled to the support member via a support frame340 that is also attached to the support member.

In this embodiment sealing, however, assembly 304 takes the form of asingle cushion 305 attached or attachable to the support member, ratherthan a pair of nasal prongs or cannulae. Support member 302 is a rigid,semi-rigid, or flexible tube having a cylindrical shape with a passage306 defined therein. Of course, other shapes and configurations forsupport member are contemplated by the present invention.

Cushion 305 is sized and configured to seal around the nares of the userand includes a single opening 308 to communicate the user's airway withpassage 306 in support member 302. Thus, the area of contact between thesealing portion of the patient interface device and the surface of theuser is limited. As example of a cushion suitable for use in the presentinvention that seals in this area is described in the '410 applicationand in U.S. Pat. No. 5,742,965, the contents of which are incorporatedherein by reference. A patient contacting surface 314 of cushion 305 iscontoured, e.g., saddle-shaped, to match, at least generally, thesurface of the user around the nose.

Cushion 305 can be made from any suitable material, such as gel (see thegel references), silicone, foam, rubber, or combination of materials.Cushion 305 can also be formed from a highly elastic material, such thatthat disclosed in U.S. patent application Ser. No. 11/266,808, thecontents of which are incorporated herein by reference. The presentinvention further contemplates that cushion 305 includes one or moreflaps provided at a patient contacting portion of the cushion. Note thatonly one flap 316 is show in the figures. An example of a cushion havingmultiple flaps is disclosed in U.S. Pat. No. 4,971,051, the contents ofwhich are incorporated herein by reference. Furthermore, cushion 305 caninclude other structures, such as ribs, support members, varying wallthickness, and pleats to control the sealing characteristic of thecushion. As example, of a cushion having pleats suitable for use in thepresent invention is disclosed in U.S. patent application Ser. No.11/312,026 (publication no. 20060130844), the contents of which areincorporated herein by reference.

It is to be further understood that the cushion 305 can have other sizesand configurations and overlie or seal against other portions of theuser, in particular, the face of the user. FIGS. 37 and 38, for example,describe a cushion having a sealing area that extends over the noseand/or around the mouth.

Cushion 305 can be attached to support member 302 using any conventionaltechnique. However, in the illustrated embodiment, the cushion isattached to the support member by means of a coupling structure 318provided in or coupled to cushion 305. More specifically, couplingstructure 318 is a rigid or semi-rigid member that is embedded in thematerial forming the cushion. A portion or portions of the couplingstructure, such as tabs 324, extend from the cushion to engage a grooveor grooves provided in the support member.

The coupling structure and the cushion are coupled to one another in anyconventional manner. However, in an exemplary embodiment, the cushion ismolded over the coupling structure. To ensure a secure attachment of thecushion to coupling structure 318, a plurality of openings 326 areformed in the coupling structure so that the material defining thecushion can flow into these openings during the cushion molding process.An example of a cushion and coupling structure suitable for use in thepresent invention to attach the cushion to the support member isdisclosed in U.S. patent application Ser. No. 11/374,942 (publicationno. 20060231103), the contents of which are incorporated herein byreference. FIG. 29 discussed below also illustrates details of such acoupling structure.

As shown in FIG. 21, when patient interface device 300 is donned by theuser, cushion 305 seals around both nares and the remainder of thepatient interface device remains below the eyes 24. Pads 312 and 322overlie only regions 20 and 30, respectively, so that the force impartedagainst the surface of the face is directed to the regions and is notdirected to any other portion of the face.

FIGS. 22-26 illustrate a fourth embodiment of a patient interface device400 according to the principles of the present invention. Patientinterface device 400 includes a support member 402 and a sealingassembly 404 coupled to the support member. Support member 402 includesan internal passage or lumen 406 that serves as a pathway for the flowof gas to and from the user. As in the previous embodiment, one or bothends of support member 402 are coupled to a pressure support system asdescribed in greater detail below.

In an exemplary embodiment, support member 402 includes a semi-rigid orflexible conduit member 430 and a brace member 432, which is generallymore rigid that the conduit member. The conduit member and the bracemember are coupled together to define the support member. They arecoupled together in any suitable fashion such that the brace memberremains external or outside of the conduit member. In an exemplaryembodiment, conduit member 430 includes a groove that receives bracemember 432, fully or partially, when these two components are assembled.Thus, when assembled, the conduit member and the brace member do notmove relative to one another, but together they define a unitarycomponent of the patient interface device that support the patientsealing portion, i.e., the portion that sealing against the patient'sairway.

Brace member 432 includes a first end portion 434 in the form of a ringand/or flange, a second end portion 436 also in the form of a ringand/or flange, and a strut 438 that extends between the first and secondend portions. In an exemplary embodiment, conduit member 430 is formedfrom a material, such as injection silicone or TPE, which can be thesame as the sealing element in a unitary structure, and brace member 432is formed from a more rigid material, such as polycarbonate, Hytrel, PP,HDPE, or flexible Nylon. Of course the present invention contemplatesother configurations, materials, or combinations of materials for thebrace member, the conduit member, or portions thereof.

As best shown in FIG. 25, the end portions of conduit member 430 aremounted to first and second end portions 434 and 436 of the brace memberby inserting the end portions of the conduit member into the first andsecond end portions of the brace member. A tongue and groove mechanismretains the brace member coupled to the flexible member. In addition orin the alternative, the conduit member and brace member are sized suchthat one or both of these members must bend or give, at least slightly,in order to insert the ends of the conduit member into the end portionsof the brace member. Once in place, they return to the original positionand are maintained in an engaged relation due to their resilient nature.

Sealing assembly 404 is a pair of nasal prongs 405 a and 405 b eachhaving a “mushroom” configuration. That is, a conical or conical-shapedhead 407 is mounted on a stem portion 409 so that gas is communicatedfrom passage 406 to the user through the hollow interior of the nasalprong. Openings 408 a and 408 b are defined in the head of the nasalprongs to communicate the gas to the user's airway. In the illustratedembodiment, sealing assembly 404 is integral with conduit member 430. Itis to be understood, however, that the present invention contemplatesthat the sealing assembly can be selectively attachable, i.e.,separable, from the conduit member so that the nasal prongs can beeasily replaced and/or so that other size, shaped, and configuredsealing devices can be used as the sealing assembly. For example, thepresent invention contemplates using a cushion, such as cushion 305discussed above, as sealing assembly 404.

A first pad 412 is mounted on a first pad support 410 that is coupled tosupport member 402. More specifically, in the illustrated exemplaryembodiment, first pad support 410 is coupled to first end portion 434 ofbrace member 432 such that the first pad support rotates relative to thesupport member 402, as indicated by arrow B in FIG. 24. Similarly, asecond pad 422 is mounted on a second pad support 420 that is coupled tosupport member 402. More specifically, in the illustrated exemplaryembodiment, second pad support 420 is coupled to second end portion 436of brace member 432 such that the second pad support rotates relative tosupport member 402. That is, both the first and the second pad supportsrotate around a common axis, which a longitudinal axis 439 for thepatient interface device. First and second pads 412 and 422 are thecontacting members of patient interface device 400 that contact regions20 and 30 on the face of the user.

In the illustrated embodiment, first and second pads 412 and 422 aregenerally elliptical or oval shaped with smooth rounded edges. Inaddition, first and second pad supports 410 and 420 each have an angledarm, where the angle is selected to correspond, generally, the curvatureof the average human head. That is, the arms of the pads supports areangled to substantially match the curvature of arc 38. See FIG. 1C. Thisconfiguration maximizes patient fit, and, hence, comfort so that thepatient interface can be warn for an extended period of time.

It is to be understood, however, that pads 412 and 422, as well as padsupports 410 and 420, can have any one of a variety of configurations,so long as the contacting area on the user is limited to regions 20 and30 discussed above. In addition, first pad 412 and second pad 422 neednot have symmetrical configurations. Likewise, first pad support 410 andsecond pad support 420 need not have symmetrical configurations.

Pads 412 and 422 can be made from any suitable material, such as gel,foam, silicon, or any combination thereof. In addition, the pads can bepermanently attached to first and second pad supports 410 and 420 usingany conventional technique, such as an adhesive or mechanical coupling.Conversely, the pads can be removably attached to the pad supports, alsousing any conventional technique, such as snaps, hook and loopfasteners, or clips. First and second pad supports 410 and 420 can alsobe made from any suitable material or combination of materials so longas the pad supporting function is achieved. In one embodiment, the padsupports are made from a rigid material. In another embodiment, they aremade from a semi-rigid or flexible material so that they can “flex” tooptimize patient comfort.

A first headgear support 442 and a second headgear support 444 arecoupled to support member 402. In an exemplary embodiment, the headgearsupports are relatively rigid members that are rotatably attached to thesupport member so that they two can be rotated about axis 439, asindicated by arrow C in FIG. 24. More specifically, a ring portion offirst headgear support 442 connects to first end portion 434 of supportmember 402 using a tongue and groove configuration. Of course, thetechnique for connecting the headgear supports to the support member isnot limited to that shown. Other techniques are contemplated includingmerely reversing the tongue and groove orientations.

Headgear supports 442 and 444 include arms 452 and 454, respectively,each of which extends away from axis 439 at an non-90° angle withrespect to that axis. In an exemplary embodiment, the angle of arms 452and 454 is selected to that the headgear straps remains generallyparallel to the surface of the user when the patient interface deviceand headgear assembly are donned by the user. The present invention alsocontemplates forming one or both arms 452 and 454 from a flexible orsemi-rigid material so that they and flex to allow the headgear strap toalign itself relative to the patient and/or the patient interface deviceas the straps are tightened.

A portion of a headgear assembly, such as a strap (shown in phantomlines 450 in FIG. 26), attaches to first headgear support 442 and secondheadgear support 444 in any suitable fashion so that patient interfacedevice 400 can be held on the user. In the illustrated exemplaryembodiment, first headgear support 442 includes a first slot 446 andsecond headgear support 444 includes a second slot 448. The headgearstraps insert into the slots and the free end is coupled back to thestrap using any suitable configuration, such as a snap or hook and loopconnector. Of course, any technique for connecting the headgear to theheadgear supports are contemplated by the present invention.

Conduit coupling 456 are provided at a first end of support member 402and at a second end of the support member opposite the first end.Conduit couplings 456 couple patient circuit 12 to each end of thepatient interface device. In the illustrated embodiment, the conduitcouplings are connected to support member 402 or to headgear supports442 and 444, which are connected to the support member. In a stillfurther embodiment, conduit couplings 456 are connected to the supportmember such that they are rotatable relative to the support member, asindicated by arrow D, in FIG. 24.

In the illustrated embodiment, conduit couplings 456 are angled toredirect the gas carrying conduits in a desired direction. While theconduit couplings are shown as having a generally 90° angle, any anglesuitable angle is contemplated by the present invention, including a 0°angle. In an exemplary embodiment of the present invention, conduitcouplings 456 are formed from a rigid material. However, the presentinvention also contemplates the conduit couplings can be formed from aflexible or semi-rigid material, or a combination of materials.

Exhaust assemblies 450 are provided on conduit couplings 456. As withthe exhaust assemblies of the previous embodiments, exhaust assemblies450 are provided to vent gas from the interior of the patient interfacedevice to ambient atmosphere. The present invention contemplates thatexhaust assemblies 450 can have any configuration, so long as thefunction of exhausting a sufficient amount of gas to atmosphere isachieved. In the illustrated embodiment, exhaust assemblies 450 aredefined by a plurality of vent holes provided in the wall of conduitcouplings 456. The present invention contemplates that the pattern ofthe holes, size of each hole, number of holes, and the location of theholes, can be changed from that shown, including providing the holes onother components of the patient interface device.

From the above description, it can be appreciated that by allowing padsupports 410 and 420, headgear supports 442 and 444, conduit couplings456 or any combination thereof to rotate, patient interface device 400can be adjusted to fit a wide variety of different patients. In anexemplary embodiment, the rotation of one or more components is acontinuous, i.e., non-discrete, so that each component can move over awide range of dimensions. This makes it possible for each of theserotatable components to “self-align” on the user. That it, when thepatient interface device is donned by they user, each component that isallowed to rotate will seeks its natural position. Thereby providing ahigh degree of flexibility in fitting a commonly sized patient interfacedevice on a wide variety of users.

In a further embodiment, one or more of the rotatable components arerotatable over a discrete number of positions in a ratchet-like fashion.This enables the user to select the desired position of each componentand maintain the patient interface device in the selected position.

Because of the rotatable relation between the various components, it ispossible to move support member 402 in a rotatable fashion relative tothe other components, as indicated by arrow E in FIG. 24. It is to befurther understood that other features and elements can be use withpatient interface device. For example, alignment indicators can beprovided on one or more of the rotating components to indicate theangular position of one component relative to another component.

FIGS. 27-31 illustrate a fifth embodiment of a patient interface device500 according to the principles of the present invention. Patientinterface device 500 includes a support member 502 and a sealingassembly 504 coupled to the support member. In the illustrated exemplaryembodiment, support member 502 is a relatively rigid or semi-rigid tubehaving an internal passage or lumen 506 defined therein that serves as apathway for the flow of gas to and from the user. As in the previousembodiments, one or both ends of support member 502 are coupled to apressure support system as described in greater detail below. Inaddition, an opening 507 is provided in support member 502 tocommunicate gas to and from sealing assembly 504.

Exhaust assemblies 550 are provide at each end of the support member. Asshown in detail in FIG. 29, the exhaust assemblies are formed bysecuring an exhaust plate 552 over an opening 554 in the support member.This allows for flexibility in the selection of the characteristics ofthe exhaust assembly merely by securing different exhaust plates to thesupport member.

Sealing assembly 504, in this illustrated exemplary embodiment, is asingle cushion 505, which is similar, if not identical, to supportcushion 305 discussed above. Cushion 505 is sized and configured to sealaround the nares of the user and includes a single opening 508 tocommunicate the user's airway with passage 506 in support member 502.Cushion 505 is attached to support member 502 in any conventionaltechnique. However, in the illustrated embodiment, the cushion isattached to the support member by means of a coupling structure 518provided in or coupled to cushion 505. Coupling structure 518corresponds to coupling structure 318 discussed above, and is a rigid orsemi-rigid member that is embedded in the material forming the cushion.A portion or portions of the coupling structure, such as tabs 524,extend from the cushion to engage a groove or grooves provided in thesupport member.

The coupling structure and the cushion are coupled to one another in anyconventional manner. However, in an exemplary embodiment, the cushion ismolded over the coupling structure. To ensure a secure attachment of thecushion to coupling structure 518, a plurality of openings 526 areformed in the coupling structure so that the material defining thecushion can flow into these openings.

Patient interface device 500 includes a support frame 540 that has agenerally curved shape. The radius of curvature for the support frame isselected to generally match the radius of arc 38 discussed above.Support frame 540 is made from any suitable material or combination ofmaterials. However, in an exemplary embodiment, support frame 540 isformed from a semi-rigid material so that the support frame can flex toincrease or decrease its radius of curvature to suit the particularfacial features of the user. Support frame 540 includes headgearattachment slots 542 to receive headgear strap 460. In the illustratedembodiment, support frame and is coupled to support member 502 asdiscussed above with respect to support frames 140, 240, and 340.

A first pad 512 is coupled to support frame 540 via a pad support 510,and a second pad 522 is coupled to an opposite end of the support framevia a pad support 520. In this exemplary embodiment, pads 512 and 522are formed from a flexible material, such as silicone, and have acylindrical or barrel shape with one more hollow chambers definedtherein. This allows the pads to give or compress while also increasingthe contact area, and hence the distribution of the load as the usertightens the mask on his or her face. In this embodiment, pad supports510 and 520 are unitarily formed with the associated pad. Thus, the padand pad support are a single piece, as best shown in FIG. 29. Of course,the present invention contemplates that the pads and pad supports can beformed from separate components and attached together in any suitablemanner, either permanently or separably.

Pad supports 510 and 520 are coupled to support frame 540 by inserting aportion of the pad support into a pad support slot 546 defined in thesupport frame. The pad support include a flexible flange 528 thatcompresses to allow the pad supports to insert into the pad supportslots and rebounds back to substantially their original shape to preventthe pad supports from readily pulling out of the pad support slots. Thepad supports are removed from the support frame simply by pulling onthem with sufficient force to cause the flange to deflect therebyreleasing the pad support from slot 546. The shape, size, andconfiguration of pad supports 510 and 520, flange 528, and slots 546 canbe varied. In addition, the present invention contemplates providingmultiple pad support slots on the support frame so that the user canselect the appropriate slot that allows the pads to be positioned onregions 20 and 30 discussed above. Also, other techniques for attachingthe pad supports to the support frame, permanently or removable, arecontemplated by the present invention.

Conduit couplings 556 are provided at each end of support member 502 tocouple patient circuit 12 to each end the patient interface device. Inthe illustrated embodiment, the conduit couplings are connected tosupport member 502 such that they rotate relative to the support member,as indicated by arrow F, in FIG. 28. This allows the position of thepatient circuit to be adjusted and prevent or minimizes movement of thepatient circuit from imparting a torque on the patient interface device.Such torque is known to dislodge or degrade the seal provided by thesealing assembly.

FIGS. 32-36 illustrate a sixth embodiment of a patient interface device600 according to the principles of the present invention. Patientinterface device 600 includes a support member 602 and a sealingassembly 604 coupled to the support member. In the illustrated exemplaryembodiment, support member 602 includes a flexible or semi-rigid conduitmember 630 and a relatively rigid or semi-rigid brace member 632. Aninternal passage or lumen 606 is defined in the conduit member thatserves as a pathway for the flow of gas to and from the user. As in theprevious embodiments, one or both ends of support member 602 are coupledto a pressure support system.

Unlike the other embodiments, in this embodiment, brace member 632 isprovided within conduit member 630 such that the brace member, orportions thereof, are disposed in passage 606. The brace member includesa central bar or rod 614 and end portions 616. The end portions of thebrace member are coupled to end portions of conduit member 630, forexample, by means of a friction fit. Thus, the brace member and theconduit member form a unitary component with the brace member providingthe structural support for the support member and the conduit memberforming the gas carrying conduit. Openings 618 are provided in endportions 616 so that gas from the patient circuit can flow to and frompassage 606. It is to be understood that the brace member and theconduit member can have configurations other than those shown.

Sealing assembly 604 is a pair of nasal prongs 605 a and 605 b eachhaving a “mushroom” configuration and a stem 607 that is integrallyformed with conduit member 630. It is to be understood, however, thatthe present invention contemplates that the sealing assembly can beselectively attachable, i.e., separable, from the conduit member so thatthe nasal prongs can be easily replaced and/or other size, shaped andconfigured sealing devices can be used in combination as the sealingassembly. The present invention contemplates using a cushion, such ascushion 305 or 505 discussed above, as sealing assembly 604. The cushioncan be integral, separably, or permanently joined to conduit member 630.

A first pad support 610 is coupled to a first end portion 608 of supportmember 602, and a second pad support 620 is coupled to a second endportion 609 of the support member. More specifically, in the illustratedembodiment, as perhaps best shown in FIG. 35, the first and second padsupports are coupled to end portions of conduit member 630 and endportions of brace member 632. Of course, the present inventioncontemplates that the pad supports need only be coupled, directly orindirectly, to one of these components of the support member. The firstand second pad supports are either rotatably coupled to the ends of thesupport member or fixed to the ends thereof using any suitabletechnique. When rotatably coupled, the first and second pads supportsrotate around a longitudinal axis 639 of the patient interface device,as indicated by arrow Gin FIG. 33.

Pad supports 610 and 620 each include an arm 611 and 621, respectively,that extends at an angle away from the portion of the pad support thatis joined to the support member. This angle of each arm is selected tocorrespond, generally, the curvature of the average human head, i.e.,arc 38 of FIG. 1C. The pad supports, arms, or both are formed from anysuitable material. For example, the present invention contemplatesforming arms 611 and 621 such that they can flex or bend, at leastslightly. Pad supports 610 and 620 each include at least one headgearattachment slots 642 to receive headgear strap 460.

A first pad 612 is coupled to first pad support 610, and a second pad622 is coupled to second pad support 620. In this exemplary embodiment,pads 612 and 622 are formed from a flexible material, such as silicone,gel or foam or a combination of materials, and have a circular orelliptical shape with one or more hollow chambers defined therein. Thisallows the pads to give or compress while also increasing the contactarea, and hence the distribution of the load as the user tightens themask on his or her face.

Pads 612 and 622 include an attachment portion, 613 and 623,respectively, to selectively attach the pad to the associated padsupport. More specifically, pads 612 and 622 are coupled to pad supports610 and 620 by inserting at least a portion of the attachment portioninto a pad support slot 646 defined in pad supports 610 and 620.Attachment portions 613 and 623 include a flexible flange 628 thatcompresses to allow the pad to insert into the pad support slots andrebounds back to substantially their original shape to prevent the padfrom readily pulling out of the pad support slots. The pads are removedfrom the support frame simply by pulling on them with sufficient forceto cause the flange to deflect thereby releasing the pad support fromslot 646.

The shape, size, and configuration of pad supports 610 and 620,attachment portions 613 and 623, flange 628, and slots 646 can bevaried. In addition, the present invention contemplates providingmultiple pad support slots on the pad supports so that the user canselect the appropriate slot that allows the pads to be positioned onregions 20 and 30 discussed above. Also, other techniques for attachingthe pad supports to the support frame, permanently or removably, arecontemplated by the present invention.

Conduit couplings 656 are provided at a first end of support member 602and at a second end of the support member opposite the first end.Conduit couplings 656 couple patient circuit 12 to each end the patientinterface device. In the illustrated embodiment, the conduit couplingsare connected to support member 602 or to pad supports 610 and 620,which are connected to the support member. In a still furtherembodiment, conduit couplings 656 are connected to the support membersuch that they are rotatable relative to the support member, asindicated by arrow H, in FIG. 33.

Exhaust assemblies 650 are provided on conduit couplings 656. As withthe exhaust assemblies of the previous embodiments, exhaust assemblies650 are provided to vent gas from the interior of the patient interfacedevice to ambient atmosphere and can have any configuration, so long asthe function of exhausting a sufficient amount of gas to atmosphere isachieved. In the illustrated embodiment, exhaust assemblies 650 aredefined by a plurality of vent holes provided in the wall of conduitcouplings 656. The present invention contemplates that the pattern ofthe holes, size of each hole, number of holes, and the location of theholes, can be changed from that shown, including providing the holes onother components of the patient interface device.

FIGS. 37 and 38 are front and rear perspective views, respectively, of aseventh embodiment of a patient interface device 700 according to theprinciples of the present invention. Patient interface device 700includes a support member 702 and a sealing assembly 704 coupled to thesupport member. This embodiment is provided to show that the sealingassembly can have still other configurations.

In this illustrated exemplary embodiment, sealing assembly 704 is a fullface mask that seals both the nose and mouth of the user. The sealingassembly includes a faceplate 760 that is coupled to support member 702.An opening 708 in the support member communicates the interior of thesupport member with a chamber defined by the faceplate. A cushion 762 orsealing element is coupled to the faceplate to form a seal with thesurface of the user. Faceplate 760 and cushion 762 can haveconfiguration so long as they accomplish the function of sealing thepatient airway in a leak resistant manner. For example, cushion 762 canhave multiple flaps at the distal end, which the end closest to thesurface of the patient. Cushion 762 can have a balloon configuration andcan include pleats or gussets at one or more locations.

The present invention also contemplates that the sealing assembly sealsonly the nares, as in the previous embodiment, but covers at portion ofthe nose, such as the bridge of the nose. In addition, the faceplate canbe eliminated entirely so long as the cushion is structurally strongenough to seal effectively with the surface of the user.

As in the previous embodiments, patient interface device 700 includespads 712 and 722 coupled to a support frame 740, which itself is coupledto support member 702. Headgear straps 460 attach to the support frame.Conduit couplings 756 are provided at one or both ends of support member702, either in a rotating or a fixed relation to couple patient circuit12 to the support member.

The present invention contemplates that the patient interface device ofthe present invention can include other features. For example, a port,typically for pressure or temperature monitoring or oxygen delivery, canbe provided in any portion in the patient interface device. In addition,the patient contacting portions can be made from any suitable materialor combination of materials that function for the intended purpose. Anyrotatable coupling between two components of the patient interfacedevice can have a continuous range of settings or a discrete range ofsetting. The present invention also contemplates that any headgearassembly can be used with the patient interface device.

It can also be observed from the foregoing description of the inventionthat if the support member is relatively strait and the pads are coupledto the support member, as is the case in FIGS. 5-26 and 32-36, the padsupport elements are angled to match the curvature of the human face,i.e., arc 38, so that the pads are properly positioned or orientedrelative to the surface of the user. If, on the other hand, the supportmember is relatively strait, but the pads are connected to a curved orcurvable support, as is the case in FIGS. 27-31, 37 and 38, the padsupport elements that couple need not be angled, but can directlyconnect the pads to the curved support element.

The present invention also contemplates that the patient interfacedevice of can include additional support structures that contact otherportions of the head of the user, so long as the other portions areabove the eyes, below the mouth, or both. For example the patientinterface device or a patient interface assembly using the patientinterface device of the present invention can include a foreheadsupport, a chin support, or both. An example of a suitable foreheadsupport is disclosed in U.S. patent application Ser. No. 10/654,379(publication no. 20040045551), the contents of which are incorporatedherein by reference. An example of a suitable chin support is disclosedin U.S. patent application Ser. No. 11/048,680 (publication no.20050205096), the contents of which are incorporated herein byreference. An example, of a combined forehead and chin support isdisclosed in U.S. patent application Ser. No. 10/953,642 (publicationno. 20050072428), the contents of which are incorporated herein byreference. It should be emphasized that regions 20 and 30, which are thearea of limited support, are located in an area of the face that isbelow the eyes and above the mouth. That is, as to the area of the faceabove the mouth and below the eyes, the patient interface device of thepresent invention contacts the user for support purposes only in regions20 and 30.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A patient interface device comprising: a supportmember; a sealing assembly operatively coupled to the support member,wherein the sealing assembly is adapted to contact a user andcommunicate a flow of gas to an airway of the user; a first supportframe having a first coupling end and a first arm extending from thefirst coupling end, the first coupling end being operatively coupled toa first end portion of the support member such that the first supportframe is moveable relative to the support member, wherein a distal endof the first arm includes a first headgear attachment slot; a secondsupport frame having a second coupling end and a second arm extendingfrom the second coupling end, the second coupling end being operativelycoupled to a second end portion of the support member opposite the firstend portion such that the second support frame is moveable relative tothe support member, wherein a distal end of the second arm includes asecond headgear attachment slot, wherein the first support frame isseparate from the second support frame; a first contacting memberoperatively coupled to the first arm of the first support frame betweenthe first coupling end and the first headgear attachment slot; a secondcontacting member operatively coupled to the second arm of the secondsupport frame between the second coupling end and the second headgearattachment slot, wherein the first support frame and the second supportframe are flexible or semi-rigid, and wherein the first contactingmember and the second contacting member are each configured and arrangedto contact the user over a limited contacting region, and wherein thelimited contacting region corresponds to a junction of the orbicularisoris facial muscle, the zygomaticus facial muscle, and the risoriusfacial muscle, but does not overly the zygomatic bones.
 2. The patientinterface device of claim 1, wherein the sealing assembly comprises apair of prongs, a cushion, or a cushion and a faceplate.
 3. The patientinterface device of claim 1, further comprising: a headgear assemblyoperatively coupled to the support member; an exhaust assemblyoperatively coupled to the support member; or both the headgear assemblyand the exhaust assembly.
 4. The patient interface device of claim 1,wherein the sealing assembly is rotatable relative to the firstcontacting member and the second contacting member.
 5. The patientinterface device of claim 1, wherein the first support frame isrotatable relative to the support member, and wherein the second supportframe is rotatable relative to the support member.
 6. The patientinterface device of claim 1, wherein the first support frame is sizedand configured to extend along a first side of a face responsive to thepatient interface device being worn by the user, wherein the secondsupport frame is sized and configured to extend along a second side ofthe face responsive to the patient interface device being worn by theuser, wherein the first contacting member is coupled to the firstsupport frame so as to protrude toward the user, and wherein the secondcontacting member is coupled to the second support frame so as toprotrude toward the user.
 7. The patient interface device of claim 1,wherein the support member includes a conduit member having an internalpassage and a brace member provided within the conduit member such thatat least a portion of the brace member is disposed in the internalpassage.
 8. The patient interface device according to claim 7, whereinthe brace member includes a first end portion, a second end portion, anda central bar provided between the first end portion and the second endportion.
 9. The patient interface device according to claim 8, wherein afirst end of the conduit member and the first end portion of the bracemember are received within the first coupling end and a second end ofthe conduit member and the second end portion of the brace member arereceived within the second coupling end.
 10. A patient interface devicecomprising: a support member; a sealing assembly operatively coupled tothe support member, wherein the sealing assembly is adapted to contact auser and communicate a flow of gas to an airway of the user; a firstsupport frame having a first coupling end and a first arm extending fromthe first coupling end, the first coupling end being operatively coupledto a first end portion of the support member such that the first supportframe is moveable relative to the support member, wherein a distal endof the first arm includes a first headgear attachment slot; a secondsupport frame having a second coupling end and a second arm extendingfrom the second coupling end, the second coupling end being operativelycoupled to a second end portion of the support member opposite the firstend portion such that the second support frame is moveable relative tothe support member, wherein a distal end of the second arm includes asecond headgear attachment slot, wherein the first support frame isseparate from the second support frame; a first contacting memberoperatively coupled to the first arm of the first support frame betweenthe first coupling end and the first headgear attachment slot; a secondcontacting member operatively coupled to the second arm of the secondsupport frame between the second coupling end and the second headgearattachment slot, wherein the first support frame and the second supportframe are flexible or semi-rigid, wherein the first contacting memberand the second contacting member are each configured and arranged tocontact the user over a limited contacting region, and wherein thelimited contacting region corresponds to an area over a maxilla at acanine fossa region, which includes a valley at a base of a zygomaticbone but does not overlie the zygomatic bones.
 11. The patient interfacedevice of claim 10, wherein the sealing assembly comprises a pair ofprongs, a cushion, or a cushion and a faceplate.
 12. The patientinterface device of claim 10, further comprising: a headgear assemblyoperatively coupled to the support member; an exhaust assemblyoperatively coupled to the support member; or both the headgear assemblyand the exhaust assembly.
 13. The patient interface device of claim 10,wherein the sealing assembly is rotatable relative to the firstcontacting member and the second contacting member.
 14. The patientinterface device of claim 10, wherein the first support frame isrotatable relative to the support member, and wherein the second supportframe is rotatable relative to the support member.
 15. The patientinterface device of claim 10, wherein the first support frame is sizedand configured to extend along a first side of a face responsive to thepatient interface device being worn by the user, wherein the secondsupport frame is sized and configured to extend along a second side ofthe face responsive to the patient interface device being worn by theuser, wherein the first contacting member is coupled to the firstsupport frame so as to protrude toward the user, and wherein the secondcontacting member is coupled to the second support frame so as toprotrude toward the user.
 16. The patient interface device of claim 7,wherein the support member includes a conduit member having an internalpassage and a brace member provided within the conduit member such thatat least a portion of the brace member is disposed in the internalpassage.
 17. The patient interface device according to claim 16, whereinthe brace member includes a first end portion, a second end portion, anda central bar provided between the first end portion and the second endportion.
 18. The patient interface device according to claim 17, whereina first end of the conduit member and the first end portion of the bracemember are received within the first coupling end and a second end ofthe conduit member and the second end portion of the brace member arereceived within the second coupling end.